The present invention is the result of applicant's association with the treatment of colostomy continuously over a period upward of 40 years. His father had colostomy for 17 years. Applicant made many inventions in this art during this period and was granted 14 United States patents and was also engaged in the manufacture and sale of colostomy appliances.
This invention provides an improved appliance comprising only three components, a pouch for receiving the fecal discharge from the stoma, a gasket of unique construction, and a belt for holding the appliance on a patient. The gasket is unique in that it is molded in a single operation to form a unitary structure having plural portions which have different functions serving all the requirements of the appliance without the use or need of extra or extraneous parts or devices.
The term "ostomy" has come into use to define, in a broad sense, the surgical procedures known as colostomy, ileostomy, cecostomy, ureterostomy, ileal conduct, ileal bladder, wet colostomy, etc. This surgery usually results in an artificial opening through the abdominal wall for the terminal end of the intestine or duct called a stoma to discharge the body wastes of feces or urine. Many devices have been developed through the years to aid in the treatment of ostomy patients, but none has been suitable for all patients. This is due to the lack of satisfactory appliances and to the differences in surgical techniques and the physiological condition of patients.
In a broad sense, the problem facing most patients is to collect the fecal discharge from the stoma in some kind of container without restricting the patient's general activities. A specific problem encountered by many patients is to prevent the discharge from contacting the skin surrounding the stoma as it can cause excoriation of the skin which is painful. Heretofore, face plates of appliances have been cemented to the skin to prevent excoriation but they are only useful for a limited time. Karaya gel seals have been used in an effort to eliminate the problem of excoriation; however, karaya is not satisfactory. Some of the objections are the high cost of karaya seals and the relatively short life due to the water solubility of karaya. Another objection is that the karaya gel seals do dry out and become hard and brittle on the dealer's shelves awaiting to be sold. When gel seals absorb moisture from the discharge they swell and can cause strangulation of the stoma and restrict the discharge flow. These conditions are very unsatisfactory. Furthermore, the time required to remove a gel seal and clean the area with repeated washing with soap and water and drying thoroughly before reapplication of skin preparations which can be most objectionable. And face plates that have been cemented on the skin with waterproof adhesives must be removed periodically and usually organic solvents must be applied to remove residual adhesive that remains on the skin. Organic solvents are not benefitial to the skin as they remove natural oils; also they are costly, have a bad odor, are usually inflamable, and are very time consuming.
The present invention overcomes the above objections to the high cost of kayaya gels, water solubility, strangulation of the stoma, excoriation of the skin, loss of time, and the use of adhesives and organic solvents.
The invention provides an appliance of novel construction incorporating many functions and advantages which overcome the objections to prior devices.